Exploring the theragnostic value of osimertinib in EGFR-mutated lung cancer (THEROS) - A multicentric phase II study in patients with TKI-resistant EGFR-mutated lung cancer exhibiting early metabolic response to osimertinib
EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance to erlotinib, gefitinib or afatinib who are “unknown” for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay.
To study the rate of early metabolic responses to osimertinib in patients with EGFR-mutated NSCLC and acquired TKI resistance who are „unknown“ for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy and a negative finding for EGFR T790M in a standard plasma genotyping assay.
In- and exclusion Criteria
In- and Exclusion Criteria
• Acquired resistance to a first- or second-generation EGFR-TKI (e.g. afatinib, erlotinib, gefitinib) following initial benefit (defined as objective response, or stable disease for at least 3 months)
• No tumor rebiopsy available or absence of an informative result for EGFR T790M mutation status by a SoC molecular pathology test (e.g. Sanger sequencing, PCR-based genotyping, deep sequencing) of a rebiopsy of a progressive tumor lesion
• Negative finding from EGFR T790M mutation testing in plasma-derived DNA using a SoC assay (e.g. Roche Cobas)
Phase II, multicenter-study
45147 Essen, Germany
University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
Prof. Dr. J. Wolf
Last Update: 13. June 2019